Clearance of Pathogens Causing Diarrhea, Dysentery and Urinary Tract Infections

Theralytix has created a prototype therapeutic lytic bacteriophage solution, brand name Theralytix Enteric Bacteriophage™, designed to eliminate the key bacterial pathogens responsible for diarrhea, dysentery, and urinary tract infections. This type of product is Generally Recognized as Safe (GRAS) by FDA. In 2019, the National Center for Medical Intelligence identified bacterial diarrheal disease as the number one priority among endemic and emerging infectious diseases that pose a threat to deployed U.S. forces. These data support the importance of diarrheal disease in training exercises in addition to operational settings. [Health.mil - Diarrhea and Associated Illness Characteristics and Risk Factors Among British Active Duty Service Members at Askari Storm Training Exercise, Nanyuki, Kenya, January–June 2014] During and after WW2 the Soviet Union pioneered development of bacteriophage-based products for prophylaxis and treatment of diarrheal diseases, which tend to be serious force protection issues for deployed personnel who were impacted by poor water quality and other sanitation issues. Today, these products are still widely used commercially in Russia, Poland, Georgia and other countries of the former Soviet Union. However, due to intellectual property and regulatory constraints, they have not been accessible beyond these regions. Theralytix's lead scientist, a native of Georgia, has spent 40 years working with the technology and led the only group that developed highly effective therapeutic bacteriophage cocktails since mass production began in the Soviet Union during the 1940's.  Phase 1 of this project will focus on testing the efficacy of our product, Theralytix Enteric Bacteriophage™, against a diverse array of clinical strains of Salmonella spp., Shigella spp., and Escherichia coli. Our internal testing indicates a minimum of 90% lysis for Salmonella and Shigella strains, and a minimum efficacy of 65% against tested E. coli strains. Although our product has undergone rigorous internal testing, our objective is to further confirm its efficacy through an independent source. This independent testing will involve the evaluation of additional clinical bacterial strains. In addition to military use, CDC has stated 2,195 children die daily of diarrhea (primarily caused by Shigella. [Defeating Diarrhea: CDC and Partners Tackle Causes and Consequences in Kenya and Beyond, cdc.gov]